NDC codes

FDA NDC Directory
Product NDC (as listed)50419-758Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50419-0758Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50419-758-0150419075801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-758-01)Marketed from Oct 22, 1987

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Cipro
Generic name (nonproprietary)
ciprofloxacin hydrochloride
Active ingredients
Ciprofloxacin hydrochloride — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 019537
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
Identifiers
Product ID 50419-758_1b112839-6cf0-466a-9188-86fc5b1549f9SPL ID 1b112839-6cf0-466a-9188-86fc5b1549f9SPL set ID 888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0RxCUI 197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310UNII 4BA73M5E37UPC 0350419754019, 0350419758017

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450419075801 followed by a unit qualifier and the quantity

Package 50419-0758-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections ( 1.1 ) • Bone and Joint Infections ( 1.2 ) • Complicated Intra-Abdominal Infections ( 1.3 ) • Infectious Diarrhea ( 1.4 ) • Typhoid Fever (Enteric Fever) ( 1.5 ) • Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) • Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) • Plague in adult and pediatric patients ( 1.8 ) • Chronic Bacterial Prostatitis ( 1.9 ) • Lower Respiratory Tract Infections ( 1.10 ) • Acute Exacerbation of Chro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 019537

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 019537
ProductStrengthForm · routeLabelerProduct NDC
Ciprociprofloxacin hydrochlorideCiprofloxacin hydrochloride 500 mg/1Tablet, Film coatedOralBayer HealthCare Pharmaceuticals Inc.50419-754

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Cipro (ciprofloxacin hydrochloride) NDC 50419-758 | Med-Code